Director, GCP Quality and Compliance Client Relationships

Precision for Medicine is the first global precision medicine clinical research services organization, purpose-built to improve the clinical research and development process for new therapeutics. Our novel approach integrates clinical operations excellence, with laboratory expertise, and advanced data sciences to inform every step. We apply our expertise to trials at all stages—from early development through approval—with embedded experience in oncology and rare disease. With over 2000 dedicated professionals and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe. Won’t you join us today as a Director, Quality and Compliance Client Relationships?

Position Summary

The Director, Q&C Client Relationships is responsible for partnering and building quality to quality relationships with our internal and external customers providing them with expert support based upon a deep understanding of current global Good Clinical Practice (GCP) requirements and regulatory expectations with the goal to drive best quality practices and to meet Precision’s objectives.

Essential functions of the job include but are not limited to:

• Provided strategic quality oversight across several key customer relationships.
• Partner with the designated Project Director and the customer Quality representative to develop Quality Agreements that meet the needs of both internal and external stakeholders.
• Support the internal study team to ensure quality delivery and continuous improvement.
• Partner with the designated Project Director to ensure that quality issues that occur within a study or a site are resolved across the customer relationship.
• Function as the senior Quality point of contact within the designated customer relationship for quality issue escalation.
• Establish a culture and mindset of ongoing compliance and continuous improvement in Precision’s quality standards.
• Lead Quality responses to requests for information, business development proposals and attend business development meetings as required.
• Identify/lead and participate in process and improvement initiatives in relation to quality.
• Serve as the quality management representative, providing updates to company leadership regarding the status of the customer relationship.
• Support quality and compliance capabilities presentations and client meetings.
• Provide support for bid defense meetings utilizing software and web-based applications.
• Provide quality and compliance consulting, as needed, for clients who are seeking input.
• Meet with the designated Project Director and the customer Quality representative on an ongoing basis to review the state of quality of the studies based upon key quality metrics.
• As part of the Management Team help counsel on and direct quality initiatives to Provide ICH/GCP compliance guidance throughout the clinical development life cycle enhance/ensure quality is assessed and maintained cross-functionally
• Participate in leading, maintaining and executing the corporate quality initiatives within Precision for Medicine.
• Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
• Support and mentor Quality & Compliance team members Travel up to 30% including international.
• Other duties as assigned.
  
  

Minimum Required

• Bachelor’s degree in science, healthcare, or related field of study.
• At least 10 years’ experience working in clinical research within Quality Assurance.
• Strong knowledge of the principles of ICH GCP, FDA Regulations, EU Directives and Regulations and other relevant laws, regulations and guidance’s related to the clinical research industry.
• Strong leadership presence and the demonstrated ability to influence cross-functional executive leaders.
• Experience auditing, interacting and relationship building with the public (regulators, vendors, and clients).
• Proficiency with common computer applications such as MS Office and other relevant industry computerized systems.
• Must be able to read, write, speak fluently, and comprehend the English language.
  
  

Preferred

• Relevant Industry Certification (e.g., CQA, SQA, etc.)
• CRO, Pharmaceutical and/or medical device experience
• Experience with electronic clinical trial systems (e.g., EDC, CTMS, IxRS, ePro, eQMS, etc.)
• Graduate, postgraduate degree, ideally in a scientific or healthcare discipline or relevant clinical or business equivalent.
  
  

Skills

• Excellent interpersonal and problem-solving skills, effective verbal and written communication, and computer skills.
  
  

Competencies

• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient.
• Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and compliance guidance, as well as the ability to implement.
• Proficient in Microsoft Word, Excel, and PowerPoint
• Ability to support senior leadership in Q&C Management tasks and projects, offering solutions and processes for increased efficiencies within the department.
• Ability to develop, coach and mentor Q&C staff.
• Demonstrates a solid working knowledge of e-Clinical systems/platforms.
• Demonstrates strong interpersonal skills.
• Ability to lead and inspire excellence within a team.
• Results oriented, accountable, motivated, and flexible.
• Exhibits strong self-motivation, is meticulous and able to work and plan independently as well as in a team environment.
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain positive interactions with internal and external stakeholders.
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles.
• Excellent verbal and written communications skills.
  
  

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.

Reasonable estimate of the current range

$150,000—$203,000 USD

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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC

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